Recall Z-0465-2022— Technomed Europe

Name: FDA recall Z-0465-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-08

Class II · Terminated

Class II FDA medical device recall by Technomed Europe, initiated 2021-12-08, terminated 2024-05-31. It names one FDA 510(k) clearance: K130136. Product: Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.. Reason: There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp..

Recalling firm: Technomed Europe
Classification: Class II
Status: Terminated
Initiated: 2021-12-08
Terminated: 2024-05-31
Firm location: Maastricht-Airport, N/A, Netherlands

510(k) clearances named in this recall

1 on FDA's record

K130136 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLE ELECTRODES,DISPOSABLE AND REUSABLE SUBDERMAL NEEDLE ELECTRODES,Technomed Europe·cleared 2013-07-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.

Reason for recall

There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.

Data sourced from openFDA. This site is unofficial and independent of the FDA.